Small labels, big challenges: solutions for advanced therapy labeling

Abstract

Accurate and useful labeling of advanced therapies from starting material to final drug product is critical for patient safety, compliance, and treatment delivery. In this article, the authors present label and label printing best practices for advanced therapies and discuss solutions to major challenges faced by sponsors, stakeholders, and regulators. In the context of this article, the terms "label" and "labeling" refer to in-process and final drug labels, not warning labels, package insert content, or other advisories issued and managed by regulatory agencies. As cell/tissue collection and drug product labeling are complex topics, it is also important to note and this article will focus on a few key areas, outlined below. This article will not cover other important labeling topics, including label stock, adhesives, inks, exact label content and layout (other than referring to ISBT128/SEC), label version control, label design, label testing/qualification, or label size and location.